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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR POLY/METAL HEMI
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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR POLY/METAL HEMI Back to Search Results
Catalog Number UNK HIP ACETABULAR POLY/METAL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 02/19/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the patient had painful r hemi hip.Doi: unknown, dor: (b)(6) 2021, affected side: right hip.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a device history record (mre) review, was not possible because the required lot code was not provided.
 
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Brand Name
UNKNOWN HIP ACETABULAR POLY/METAL HEMI
Type of Device
HIP ACETABULAR POLY/METAL HEMI
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11417516
MDR Text Key239570902
Report Number1818910-2021-04444
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR POLY/METAL
Was Device Available for Evaluation? No
Date Manufacturer Received03/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
28 PLUS 5
Patient Outcome(s) Required Intervention;
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